FDA Announced Additional Decisions on New Tobacco Products - Rolling Papers!

[ennagizer]

The FDA authorized the sale of three new tobacco products found to be “substantially equivalent” to marketed products in October. These products are rolling papers! I'm at a loss for words. I didn't know that rolling papers were regulated by the FDA under the tobacco act. This is where the FDA spends their resources, evaluating rolling papers to see if they are substantially equivalent as papers already on the market? Ya know, this is going to stifle innovation in the rolling paper industry.



See the section titled "Substantial Equivalence Marketing Orders" towards the middle of the page.
Tobacco Product Marketing Orders

 

[Spazmelda]

I can't even imagine how boring that job would be. Researching and writing about little scraps of paper? Yawn... I would be taking lots of naps under my desk.

 

[Nermal]

C'mon peoples. Some of those papers at least used to have (Gasp!) flavors. Try to keep up.

 

[Harlen]

What make you think they don't ????

 

[cookiebun]

What happened to the government shut down?
The FDA is considered ESSENTIAL? You've got to be kidding.

 

[NorthOfAtlanta]

What happened to the government shut down?
The FDA is considered ESSENTIAL? You've got to be kidding.

BP won't let them shut down.

 

[AgentAnia]

Ya have to laugh... Tobacco Control Board Deputy Assistant Director in Charge of Cigarette Rolling Papers Evaluation... I'm laughing till I'm crying... or maybe I'm laughing and crying at the same time...

 

[NorthOfAtlanta]

I can see him now, trying to figure out if it's bleached or unbleached papers.

 

[AgentAnia]

I can see him now, trying to figure out if it's bleached or unbleached papers.

Two positions, actually:

1. Tobacco Control Board Deputy Assistant Director in Charge of Cigarette Rolling Papers (Bleached) Evaluation...
2. Tobacco Control Board Deputy Assistant Director in Charge of Cigarette Rolling Papers (Unbleached) Evaluation...

(They awarded a $5million contract to an independent lab to determine if the papers are bleached or unbleached, at which point the lab send it to the appropriate Deputy Assistant Director in Charge of Cigarette Rolling Papers for evaluation....)

 

[ennagizer]

I just read the Marketing Orders I mentioned in the OP. If you don't want to get ...... off, don't read them. I'm in disbelief that money was spent on this and took over 2 years for approval.

It seems all the manufacturer wanted to do was market papers and filters together in the same package. Another request was for paper and filter that are a little longer than the product already on the market. Increase in tube length (from 84 to 100 mm), Increase in filter length (from 15 to 25 mm). Wow.

 

[aikanae1]

I keep thinking of the movie Brazil.

 

[stevegmu]

They need to keep finding ways to justify their 6-figure salaries.

 

[WarHawk-AVG]

They need to keep finding ways to justify their 6-figure salaries.

This is how they have 800K "non-essential" jobs

 

[stevegmu]

Meet the $325000 robo-squirrel-





He was designed to test the reaction a rattlesnake would have to him.

 

[jtpjc]

I remember a documentary about non-bleached toilet paper. The reporters called, could they come and see their factory? Yes, they were very welcome. So, how do you produce this nice white non-bleached toilet paper? Well, I don't know, let me ask. (unintelligible background talking). Sorry, I must ask you to leave now. It's ehm... a secret.

 

[Bill Godshall]

To date, FDA has received more than 4,300 SE applications (including more than 770 SE applicaions for products not yet on the market unless/until FDA approves), has approved just 2 SE applications for cigarettes and 7 SE applications for RYO products, has rejected 8 SE applications, and has reported 151 SE application withdrawals.

Unless the FDA exempts e-cigs from the February 15, 2007 date, ALL e-cigarette products currently on the market would be banned until the manufacture submits (and FDA approves) an SE application (verifying the e-cig product is the substantially equivalent to a 2007 product), or until the manufacturer submits (and FDA approves) a "New Product" application.

A separate SE or New Product application (each costing several million dollars) would have to be submitted (and approved by FDA for each e-cig product before it would be allowed to be put back on the market.

It is unlikely the FDA would approve any SE application for an e-cig product (since none of the products are substantially equivalent to any product on the market in 2007), and no applications (for any New Product) has yet to be submitted to the FDA.

 

[TTK]

It is unlikely the FDA would approve any SE application for an e-cig product (since none of the products are substantially equivalent to any product on the market in 2007), and no applications (for any tobacco product) has yet to be submitted to the FDA.

I assume "substantially equivalent" does not mean "identical", otherwise identical would have been used. So, what are the criteria for substantially equivalent? All ecigs in 2007 had a atomizer, liquid nicotine in a capsule that was vaporized by the atomizer, and a battery. All ecigs today have the same things. Of course this is coming from someone who does not know nearly as much about this as you do.

 

[Sundodger]

I keep thinking of the movie Brazil.

I keep thinking of Walter White in Breaking Bad, I can see the FDA guy testing the papers in his fingers trying to roll.

 

[ennagizer]

I assume "substantially equivalent" does not mean "identical", otherwise identical would have been used. So, what are the criteria for substantially equivalent? All ecigs in 2007 had a atomizer, liquid nicotine in a capsule that was vaporized by the atomizer, and a battery. All ecigs today have the same things. Of course this is coming from someone who does not know nearly as much about this as you do.

Info gathered from here: Tobacco Product Marketing Orders

Substantial Equivalence

Substantial equivalence is a second pathway manufacturers can use to market a new tobacco product in certain circumstances.

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product meets the following criteria:

- It was commercially marketed after February 15, 2007 but before March 22, 2011; and
- A Substantial Equivalence5 Report was submitted by March 22, 2011,
then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to a valid predicate product.

Marketing orders for substantially equivalent tobacco products can be issued for new products that have the same characteristics as valid predicate tobacco products, or have different characteristics but the new products do not raise different questions of public health.

 

[Bill Godshall]

The following FDA documents delineate how/why all e-cig products currently on the market would be banned by Section 905(j) and Section 910 of the FSPTCA, and explain how companies can submit Substantial Equivalence or New Tobacco Product applications to the FDA if they want to market the product.

Substantial Equivalence and New Tobacco Product applications
Tobacco Product Marketing Orders

Draft Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
http://www.fda.gov/downloads/TobaccoProducts/ResourcesforYou/ForIndustry/UCM271239.pdf

Draft Guidance: Establishing a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM334750.pdf

Exemption from Substantial Equivalence
http://www.gpo.gov/fdsys/pkg/FR-2011-07-05/pdf/2011-16766.pdf

New Tobacco Product Review and Evaluation
Substantial Equivalence

Draft Guidance: Applications for Premarket Review of New Tobacco Products
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdf

Guidance for SE under Section 905(j) (note that this deadline passed two years ago)
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf
Substantial Equivalence Q&A (note that the 2011 deadline passed two years ago)
Questions & Answers